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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618002015224
Ethics application status
Approved
Date submitted
27/11/2018
Date registered
17/12/2018
Date last updated
17/12/2018
Date data sharing statement initially provided
17/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of serum cardiac biomarkers and left ventricular strain imaging for detecting early radiation induced myocardial damage
Scientific title
The role of serum cardiac biomarkers and left ventricular strain imaging for detecting early radiation induced myocardial damage
Secondary ID [1] 296720 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Left ventricular dysfunction 310583 0
Breast Cancer 310584 0
Radiation Therapy 310585 0
Condition category
Condition code
Cardiovascular 309296 309296 0 0
Other cardiovascular diseases
Cancer 309297 309297 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will be assessed during routine radiation therapy for left sided breast cancer. They will be assessed with transthoracic echocardiography pre and post treatment and will undergo blood testing daily during the first week of treatment and then on day one of each subsequent week of treatment to measure cardiac biomarker levels.
Intervention code [1] 313028 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308264 0
To measure the change in serum high-sensitivity troponin and NT-pro BNP levels in patients during radiation therapy
Timepoint [1] 308264 0
Serum testing at enrolment and at the end of radiation therapy (6 weeks)
Secondary outcome [1] 354462 0
To measure the change in left ventricular strain rate in patients undergoing radiation therapy using global longitudinal strain and strain rate on transthoracic echocardiography.
Timepoint [1] 354462 0
6 weeks post-enrolment (end of radiation therapy)

Eligibility
Key inclusion criteria
All women over the age of 18 years with left sided breast cancer undergoing radiation therapy at the Olivia Newton John Cancer and Wellness Centre
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are receiving adjuvant chemotherapy or Herceptin. Patients who are unable to provide informed consent will be excluded. Additionally, patients who withdraw their consent at any stage will be excluded from the rest of the study.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Normalised data will be expressed as mean ± standard deviation. Continuous data will be evaluated by Student’s t-test or Mann-Whitney U test as appropriate. Categorical data will be expressed as n (%) and analyzed using Fisher’s exact test. Differences in paired samples will be evaluated by Wilcoxon signed-rank test. Two-tailed p-values <0.05 will be considered significant. A sample size calculation has not been performed for this preliminary investigation, as it is a pilot study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12566 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 24945 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 301300 0
Charities/Societies/Foundations
Name [1] 301300 0
Austin Health Medical Research Foundation
Address [1] 301300 0
Austin Health Cardiology Department
145 Studley Rd
Heidelberg 3084
Victoria
Country [1] 301300 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Austin Health Medical Research Foundation
Address
Austin Health Cardiology Department
145 Studley Rd
Heidelberg 3084
Victoria
Country
Australia
Secondary sponsor category [1] 300953 0
None
Name [1] 300953 0
N/A
Address [1] 300953 0
N/A
Country [1] 300953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302043 0
AUSTIN HEALTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 302043 0
Austin Health Cardiology Department
145 Studley Rd
Heidelberg 3084
Victoria
Ethics committee country [1] 302043 0
Australia
Date submitted for ethics approval [1] 302043 0
20/11/2017
Approval date [1] 302043 0
12/12/2017
Ethics approval number [1] 302043 0
HREC/17/Austin/533

Summary
Brief summary
The purpose of this study is to determine the role of blood molecules and imaging in the detection of early heart damage in women undergoing radiation treatment.

Who is it for?
You may be eligible for this study if you are over the age of 18 years, have left sided breast cancer and are undergoing radiation therapy at the Olivia Newton John Cancer and Wellness Centre in Melbourne.

Study details
All participants in this study will have a blood test on day 1 to 5 of the first week of radiation treatment and then on day 1 of each subsequent week. This will be to measure the levels of blood molecules related to heart damage. Participants will also have a heart ultrasound (echocardiogram) before they start treatment and when they finish treatment.

The intention of this study is to identify early damage to the heart muscle during radiation therapy. If we can identify those patients with early damage we can follow them into the future to ensure they do not develop symptomatic heart disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88934 0
Dr Terase Lancefield
Address 88934 0
Austin Health Cardiology Department
145 Studley Rd
Heidelberg 3084
Victoria
Country 88934 0
Australia
Phone 88934 0
+61 3 94565000
Fax 88934 0
Email 88934 0
terase.lancefield@austin.org.au
Contact person for public queries
Name 88935 0
Dr Alexandra Murphy
Address 88935 0
Austin Health Cardiology Department
145 Studley Rd
Heidelberg 3084
Victoria
Country 88935 0
Australia
Phone 88935 0
+61 3 94965000
Fax 88935 0
Email 88935 0
acmurphy@rocketmail.com
Contact person for scientific queries
Name 88936 0
Dr Alexandra Murphy
Address 88936 0
Austin Health Cardiology Department
145 Studley Rd
Heidelberg 3084
Victoria
Country 88936 0
Australia
Phone 88936 0
+61 3 94965000
Fax 88936 0
Email 88936 0
acmurphy@rocketmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data collected will be used in this study only.
What supporting documents are/will be available?
No other documents available
Summary results
No Results